Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers

Foot Ulcer, Diabetic Clinical Trial

Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Study to Assess the Safety of DERMASEAL Advanced Wound Care Dressing for the Treatment of Chronic Non-healing, Neuropathic Diabetic Foot Ulcers

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to determine the safety of DERMASEAL for the treatment of non-healing, neuropathic diabetic foot ulcers. The main outcome measure is safety. A total of twenty-four (24) participants will be randomized to receive up to four (4) consecutive weeks of treatment with either standard of care (SOC), plasma film + SOC, or plasma film containing silver microparticles (DERMASEAL) + SOC, with a final follow-up visit 12 weeks after the last treatment.

Clinical Trial Description

A double-blind, randomized, placebo-controlled, multi-center, phase 1 study to evaluate the safety of the DERMASEAL advanced wound care dressing in the treatment of non-healing diabetic foot ulcers located distal to the malleolus in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation. Subjects will be randomized in a 1:1:2 ratio to one of 3 treatment groups:

• SOC alone (n=6)

• SOC + plasma film (n=6)

• SOC + DERMASEAL (n=12)

A subject's study duration will be up to a total of 18 weeks from screening to end of study. This includes a two-week active run-in followed by up to 4 weeks of treatment, plus a final follow-up visit 12 weeks after the last treatment.

The primary endpoint is safety of topically applying a plasma film containing metallic silver microparticles plus fibrin in patients with chronic, non-healing neuropathic diabetic foot ulcers. Secondary endpoints to be assessed in each group include:

1. Percent of study wounds healed during the post-treatment weeks 1 through 4,

2. Time to complete wound closure,

3. Percent area reduction during the post-treatment weeks 2, 4, 6 and 16, and

4. Cost of treatment ;

Related Conditions & MeSH terms

• Diabetic Foot
• Foot Ulcer
• Foot Ulcer, Diabetic
• Ulcer

• NCT number: NCT05586542
• Study type: Interventional
• Source: Vitruvian Medical Devices, Inc.
• Contact: Hobart W Harris, MD, MPH
• Phone: (415) 514-3891
• Email: hobartwharris@gmail.com
• Status: Recruiting
• Phase: Phase 1
• Start date: October 3, 2022
• Completion date: March 30, 2025